PSG Tech and Clinical Research Coordinator

About the Job

Position Summary:

This position will serve as a PSG sleep technologist and Clinical Research Coordinator for a Sleep Neurologist who studies the relationship between sleep and Alzheimer's disease pathology. This position requires some experience or education as a Sleep technologist and will provide research participant care and education about sleep studies within the framework of a research trial. This role requires setting up specialized monitoring equipment for home based sleep studies and analyzing sleep stages and respiratory events.

Main duties include setting up home based sleep studies, education of participants in sleep equipment and troubleshooting equipment issues with participants, analyzing data, and ensuring all data handling complies with privacy rules. The role will also support the investigator as a Clinical Research professional coordinating clinical research trials in treatment of sleep disorders, under PI supervision.

The person who takes this position may be responsible for multiple research studies simultaneously, coordinating with the PI, IRB, sponsoring agency, community and the study participants. The role will be responsible for coordinating and recording all phases of study protocol as required by GCP and sponsoring agencies to ensure compliance. This role will be in person 2-3 days per week at the University of MN, Twin Cities campus and at clinical sites within the Twin City Metro area.

Visa sponsorship and/or relocation assistance not available for this position.

Work Schedule:

Hybrid (predominately in-person), 7:30am - 4pm, M-F

Duties/Responsibilities:

40% Sleep technologist:

* Follow protocol guidelines when collecting sleep data using polysomnography, home sleep testing, single-channel EEG devices and actigraphy.

* Score sleep research studies.

* Generates reports and enters data into electronic databases per protocol.

* Ensures secure data storage of all study materials.

40% Clinical Research Coordinator:

* Coordinates all aspects of investigator-initiated research and clinical trials with the principal investigator and senior clinical research coordinator.

* Identify, recruit, screen, obtain informed consent, educate, monitor, and follow-up with subjects.

* Under PI supervision, contribute in making determinations of eligibility based on diagnostic criteria and/or observations/analysis in participant interviews.

* Work directly with study participants educating about diagnostic procedures and study procedures and plans, explaining purpose of study and obtains consent.

* Completed study documentation following ALCOA and GCP standards.

* Addresses participant concerns, study issues, trouble shoots study issues and ensures PI is properly informed. Communicate with PI, Sponsor, IRB and other regulatory groups and participants as needed to ensure safety, adherence to protocol, AEs, SAES and understanding of studies.

* Duties must be completed in a timely manner and must comply with protocol guidelines, Good Clinical Practices (GCP), all applicable University guidelines, Standard operation procedures (SOPs), laws, and requirements of regulatory agencies.

7.5% Scheduling and Communication:

* Follow protocol to schedule study participants and timely completion of all protocol requirements (assessment, lab testing, procedures and treatments).

* Addresses participant concerns, trouble shoots study related issues and ensures PI is properly informed.

* Communicate with PI, Sponsor, IRB and other regulatory groups and participants as needed to ensure safety, adherence to protocol, AEs, SAES and understanding of studies.

7.5% Regulatory and Compliance:

* Comply with protocol guidelines, Good Clinical Practices (GCP), all applicable University guidelines, Standard operation procedures (SOPs), laws, and requirements of regulatory agencies.

* Coordinate site visits with industry sponsors; coordinate communications with funding or sponsoring agencies.

* Under supervision by lead coordinator, coordinate IRB submissions, continuing annual reviews and Serious Adverse Event reporting (SAE); assist with protocol correction action plans as appropriate.

5% Other duties as needed:

* Performs…